Change in Patient Reported Outcomes and Wish for Joint Surgery

NCT ID: NCT05455177

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14018 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-09-30

Brief Summary

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Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis (OA) comprising exercise and education.

Methods Retrospective observational registry data. All participants enrolling between June 1st 2018 and September 30th 2021 with follow-up data and with a change in their wish for surgery (dichotomous, becoming wishing or unwishing) were included. Analysed PROMS comprised pain (numeric rating scale (NRS), 0-10), 5 level EuroQol - 5-dimension (EQ5D-5L, 0.243-0.976), overall health (NRS, 0-10), activity impairment (NRS, 0-10), walking difficulties (yes/no), fear of movement (yes/no), function and quality of life subscales of Knee/Hip injury and Osteoarthritis Outcome Score 12 Items (KOOS-12/HOOS-12, both 0-100). To capture effects of changes in PROMs over time on probability of wish for surgery, the investigators used fixed effect (conditional) logistic regressions.

Detailed Description

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Conditions

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Osteoarthritis, Knee and Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Digital first-line intervention for osteoarthritis including exercise and education

The digital OA management programme was delivered by a smartphone application, including education and exercises based on a face-to-face osteoarthritis self-management programme provided nationwide in Sweden and designed according to national and international guidelines. Over 12 weeks, which is the recommended minimum duration of a self-management intervention for OA, a total of 163 exercise sessions and 31 educational sessions are provided.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of knee or hip osteoarthritis
* Date of enrolment between June 1st 2018 and September 30th 2021 (study period)
* Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)

Exclusion Criteria

* No follow-up data
* No change in wish for surgery (participants remained either wishing or not wishing to undergo surgery for the whole treatment period). This exclusion was due to the focus of the present study on within-person relationships between PROMs and wish for surgery. In this scenario, those with no change in their wish for surgery do not provide any information to the analysis.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Joint Academy

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Joint Academy

Malmo, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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JAPROMS_w

Identifier Type: -

Identifier Source: org_study_id

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